Major purpose of the Job : -As a primary role Medical writing activities for BE and CT studies includes Preparation of Protocol, ICF, CRF and Clinical study report and as a secondary role pharmacy related activities of BE and CT studies. -Submission of BE study documents to Regulatory department for BE NOC/ T license and IEC for its approval. Responsibilities: Medical Writer: -Preparation of Protocol and its Amendments for BE studies. -Preparation of ICF and CRFs for BE studies. -Preparation of Phase I, II & III Synopsis, Protocol, Protocol Amendments, ICF and CRFs for CT studies. -Preparation and Compilation of CSR for BE studies and eCTD of study report as per specific guidelines. -Designing of Pharmacokinetic time points/feasibility for BE studies. -Implementation of revisions on guidelines for medical writing and Preparation of SOP. IEC submission activities. -Submission of Protocol and other documents to regulatory department for DCGI NOC/ T license. -Handling of regulatory agency deficiencies. Pharmacist: - Management of BE and CT pharmacy. - Handling of IP including receipt, storage, dispensing, & retention of Investigational Product. - Preparation of labels related to IP handling. - Temperature data monitoring. - Archiving of all pharmacy temperature data & logbooks. -Any other additional activities assigned by Head of the department.
